Approval is based on Phase III NATALEE data showing Kisqali® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in patients with stage II or III HR+/HER2- early breast cancer (EBC), consistent across all subgroups1,2 With this broad indication, nearly twice as many EBC patients in Europe, including those with node-negative disease, could now be eligible for treatment with Kisqali to help reduce their risk of recurren

Fast Track designation indicates LBS-007’s potential in filling the unmet medical need of acute leukemia LBS-007 is the Company’s investigational medicinal product for the treatment of acute leukemia A Phase 1/2 trial in patients with relapsed or resistant acute leukemias is ongoing LBS-007, the Company’s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA Nov. 27, 2024 -- Lin BioScience (6696. Taiwan OTC), a clinical-s

Designation underscores significant unmet need in frontotemporal dementia and the potential role of neflamapimod in multiple neurologic disorders On track to report topline data from the RewinD-LB Phase 2b clinical trial in early-stage dementia with Lewy bodies (DLB) in December 2024 Nov. 27, 2024 -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing treatments for age-related neurologic disorders, today announced that its oral investigational drug neflamapimod has bee

- Preselection Method for Cancers Responding to SLS009: High Efficacy of SLS009 Observed in 67% of ASXL1 Mutated Solid Cancers vs 0% in Non-ASXL1 Mutated Cancers – - ASXL1 Mutations Predictably Identified in Colorectal Cancer (CRC MSI-H) and Non-Small Cell Lung Cancer (NSCLC) in Addition to Hematologic Malignancies - - Existing Clinical Data Demonstrating SLS009 Efficacy in ASXL1 mutated AML and Safety Across Multiple Cancer Types Lay Foundation for Targeted SLS009 Clinical Trial in Selected Sol

Nov. 25, 2024 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced the acceptance of a peer-reviewed manuscript titled, “Blarcamesine for the treatment of Early Alzheimer

TN-401 AAV9-based Gene Therapy Designed to Deliver Fully Functional PKP2 Gene with the Aim of Increasing Protein Levels to Address Underlying Disease RIDGE-1 Currently Enrolling at Six Centers; Observational Natural History and Seroprevalence Study of PKP2-associated ARVC Adults Continues Enrollment at 20 Clinical Sites in the U.S., UK and Europe Initial Clinical Data for RIDGE-1 Anticipated in 2025 Nov. 25, 2024 -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology compan

FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025 Nov. 25, 2024 -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the outcome of its recent End-of-Phase 2 in-person meeting wit

Amglidia® has been approved by the European Medicines Agency (EMA) and is commercially available in EuropeStrong strategic fit with Eton’s existing pediatric endocrinology focusAmglidia has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA)Potential New Drug Application (NDA) submission in 2026 DEER PARK, Ill., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on d

Klothea Bio Secures Funding from Longevitytech.fund as a lead investor to Pioneer Breakthrough Treatments for Metabolic Syndrome and several Aging-Associated DiseasesMIAMI, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Advantage Therapeutics Inc., a leader in developing therapies targeting age-related diseases, announced today the formation of its new subsidiary, Klothea Bio, Inc., which will focus exclusively on the research and development of Klotho-based therapies to prevent and treat various age-assoc

Nov. 25, 2024 -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to nexiguran ziclumeran (nex-z, also known as NTLA-2001) for the treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in vivo CRISPR-based invest